FDA Advisors Put Breast Implants Back in the Spotlight

From the WebMD Archives

March 1, 2000 (Washington) -- Despite emotional, sometimes tearful, testimony from women that blamed saline breast implants for ruining their lives, an FDA advisory committee recommended Wednesday that the agency give an official stamp of approval to at least one maker's devices. On March 2, the advisory committee will discuss the status of implants made by two other manufacturers, but it is now expected that these implants will receive the committee's blessings as well.

It was a deeply disappointing result for Patricia Faussett, 40, who elected to have this surgery in 1997. "I just wanted to get my pre-pregnancy shape back," she tells WebMD. But in the end, says Faussett, the implants simply resulted in severe fatigue, some loss of memory, and some lingering mental "haze." Faussett has since chosen to have the implants removed. "I feel much better now," she tells WebMD. "I don't have the same stamina, but it is much better without them."

Faussett is not alone. There were a good number of other women who gathered at the meeting to urge the FDA not to lend its approval to these devices, if not also to require their eventual withdrawal. And these people included patients such as Anne Lowder, a once successful designer who had the surgery for strictly medical reasons. "There is something definitely wrong with these devices. They ruined my life," she tells WebMD.

But at the same time, there were also a number of implant recipients that came to support the use of these devices, even if just for cosmetic reasons alone.

Karen doesn't want her last name used. She elected to have the surgery despite the protests of her husband and warnings from her physician that the implants could fail. "I am very happy with the results," she tells WebMD. The surgery was performed less than two years ago, and Karen says that she is fully aware that her implants might still fail. "It's really all about choice. ... I know the risks."

These risks include deflation, infection, and capsular contraction, a condition that occurs when scar tissue forms around the implant, resulting in painful stiffness of the breast and possible leakage of the fluid inside the implant. But despite data showing that implants might also interfere with the early detection of breast cancer, it was the testimony of witnesses like Karen that eventually played a larger role in the advisory committee's final decision.

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The committee was to determine whether long-term safety data supported the use of these devices, which hit the U.S. market prior to the passage of laws permitting the FDA to regulate medical devices. They decided that the withdrawal of at least this device was not merited if patients understood the risks.

"I found the whole issue of safety and efficacy very uncomfortable," said Karen Bandeen-Roche, PhD, a member of the FDA advisory committee. "Then I decided that the best solution is not for me to decide," she said, reflecting the committee's overall opinion.

But data presented at the meeting showed that the use of these devices, or at least those made by Mentor Corp., did incorporate a fair share of risks. About 73% of patients receiving implants for breast reconstruction after cancer and 43% of patients electing to have implants for cosmetic reasons experienced complications, when incorporating symptoms such as numbing of the nipples. And about 40% of the reconstruction patients and 13% of the cosmetic patients also had to undergo a secondary operation to remove or replace the implants within three years, primarily due to complications such as capsular contraction.

Nancy Dubler, LLB, an expert in bioethics, was the sole member of the FDA committee to vote against giving the Mentor devices the FDA's stamp of approval. "Given the deflation rate and leakage rate ... I just couldn't vote for approval," she said.

Susan Kolb, MD, a plastic surgeon who also has saline implants, sums up the reigning mood of the meeting: "I don't know the true dangers of saline. I'm my own experiment on that."